FDA Inspection
Mylan Laboratories LimitedMylan Laboratories Limited – FDA Inspection, Jan 18, 2019
Record Details
This FDA Inspection record concerns Mylan Laboratories Limited, with an inspection on January 18, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 91251600-e945-4e7b-a7ee-e222b0dd5934
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1076887
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.194(a)(1)Sample identification and other information
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
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Other FDA inspections of Mylan Laboratories Limited
8| Date | Classification | Office | Project area |
|---|---|---|---|
| May 24, 2024 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| February 7, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 12, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 14, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 25, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mylan Laboratories Limited
- FDA Inspection 1238860 - 2024-05-24
- FDA Inspection 1117137 - 2020-02-07
- FDA Inspection 1050962 - 2018-04-12
- FDA Inspection 986244 - 2016-09-14
- FDA Inspection 920472 - 2015-03-25
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